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    DEA Class; Rx

    Common Brand Names; Colazal, Giazo (dsc)

    • 5-Aminosalicylic Acid Derivatives

    Oral diazo-bonded 5-aminosalicylate (5-ASA) prodrug; releases mesalamine (5-ASA) in colon
    Capsules (e.g., Colazal) used in adult and pediatric patients 5 years and older for mild to moderately active ulcerative colitis (UC)
    Improved tolerability vs. olsalazine

    Indicated for the treatment of mildly to moderately active ulcerative colitis.


    Hypersensitivity to salicylates, balsalazide, mesalamine

    • Headache (15% peds)
    • Abdominal pain (13% peds )
    • Vomiting (10% peds)
    • Headache (8%)
    • Abdominal pain (6%)
    • Nausea (5%)
    • Diarrhea (5%)
    • Respiratory infection (4%)
    • Arthralgia (4%)
    • Vomiting (4%)
    • Fatigue (2%)
    • Insomnia (2%)
    • Cough (2%)
    • Pharyngitis (2%)
    • Rhinitis (2%)
    • Dyspepsia (2%)
    • Anorexia (2%)
    • Flatulence (2%)
    • Fever (2%)
    • Constipation (1%)
    • Cramps (1%)
    • Ulcerative colitis exacerbation (1%)
    • Flu like syndrome (1%)
    • Myalgia (1%)
    • UTI (1%)
    • Xerostomia (1%)

    Risk of exacerbation of ulcerative colitis

    Photosensitivity reported; advice patients with pre-existing skin conditions to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors

    Nephrolithiasis reported; stones containing mesalamine, the active moiety, are undetectable by standard radiography or computed tomography (CT). ensure adequate fluid intake during treatment

    Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported with use, discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation

    Mesalamine-induced hypersensitivity reactions may present as internal organ involvement, including myocarditis, pericarditis, nephritis, hepatitis, pneumonitis, and hematologic abnormalities; evaluate patients immediately if signs or symptoms of hypersensitivity reaction present; discontinue therapy if alternative etiology cannot be established

    There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine; because balsalazide is converted to mesalamine, evaluate risks and benefits of using this medication in patients with known liver impairment

    Pyloric stenosis or other organic or functional obstruction in upper gastrointestinal tract may cause prolonged gastric retention of this drug, which would delay mesalamine release in the colon; avoid this drug in patients at risk of upper gastrointestinal tract obstruction

    Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection

    Published data from meta-analyses, cohort studies and case series on use of mesalamine, the active moiety of the drug, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes

    Data from published literature report presence of mesalamine and metabolite, N acetyl-5 aminosalicylic acid, in human milk in small amounts with relative infant doses (RID) of 0.1% or less for mesalamine; there are case reports of diarrhea in breastfed infants exposed to mesalamine; there is no information on effects of drug on milk production


    6.75 grams/day PO.


    6.75 grams/day PO.


    6.75 grams/day PO.


    5 to 12 years: 6.75 grams/day PO.
    Less than 5 years: Safety and efficacy have not been established.

    Balsalazide disodium


    • 750mg (Colazal)

    tablet (dsc)

    • 1.1g (Giazo)